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EISAI to Unveil New Data on Halaven® (Eribulin) Mode of Action at San Antonio Breast Cancer Symposium 2015 (SABCS)
Hatfield, England (ots/PRNewswire) - PRESS RELEASE FOR EU MEDIA ONLY: NOT FOR SWISS/AUSTRIAN/U.S. JOURNALISTS
Studies at the upcoming San Antonio Breast Cancer Symposium (Texas, 8-11 December) will explore mode of action and highlight potential new combinations
New data at the San Antonio Breast Cancer Symposium (SABCS) will explore the distinct mode of action of Halaven® (eribulin) in which the epithelial-to-mesenchymal transition is reversed, the process by which cancerous cells are made more aggressive and harder to treat. The full results of the study, called "Eribulin affects E-cadherin localization consistent with a reversal of the epithelial-to-mesenchymal transition" will be presented as a poster (P5-03-09) at the conference on Friday 11 December (17:00-19:00 CST).
Eisai will present a total of seventeen eribulin abstracts at SABCS. Eribulin is currently indicated in Europe for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.
A further study of stage I-II Hormone receptor positive/Her2 negative breast cancer to be presented at SABCS has data suggesting that women with the aggressive, Luminal B form of the disease might benefit the most from treatment on eribulin which induces a luminal A phenotype. The study, "Efficacy and gene expression results from eribulin SOLTI1007 neoadjuvant study (https://clinicaltrials.gov/ct2/show/NCT01669252?term=SOLTI1007+neoadjuvant+study+eribulin&rank=1)", will be presented as a poster (P3-07-66) at the conference on Thursday 10 December (17:00 - 19:00 CST).
A number of other studies to be presented at SABCS will also highlight the potential of eribulin to work in combination with other therapies. One study will present the design of a phase 1b/2 study to evaluate the efficacy and safety of eribulin in combination with pembrolizumab in patients with metastatic triple-negative breast cancer. A second study will explore whether PH20 (PEGPH20) (Pegylated Recombinant Human Hyaluronidase) enhances efficacy of eribulin in triple negative breast cancer xenografts.
The full details of the seventeen eribulin abstracts are as follows:
Abstract Number Abstract Name Presentation Details OT1-03-19 Design of a Phase 1b/2 Study to Poster Session: OT1-03-19 Evaluate the Efficacy and Safety of Date: Wednesday, December 9 Eribulin Mesylate in Combination with Time: 5:00 PM-7:00 PM Pembrolizumab in Patients with Metastatic Triple-Negative Breast Cancer P3-07-39 CASCADE study: Treatment and clinical Poster Session: P3-07-39 outcomes of metastatic breast cancer by Date: Thursday, December 10 tumor immunophenotypes Time: 5:00 PM-7:00 PM OT3-02-11 Phase 2 Study Evaluating the Efficacy Poster Session:OT3-02-11 and Safety of Eribulin Mesylate Date: Friday, December 11 Administered Biweekly for Subjects With Time: 5:00 PM-7:00 PM Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer P1-12-05 Phase 2 study of dose-dense doxorubicin Poster Session: P1-12-05 and cyclophosphamide followed by Date: Wednesday, December 9 eribulin mesylate with or without Time: 5:00 PM-7:00 PM prophylactic growth factor for adjuvant treatment of early-stage breast cancer P6-08-07 Association between phenotype of triple Poster Session: P6-08-07 negative breast cancer cell lines and Date: Saturday, December 12 sensitivity against eribulin mesylate Time: 7:30 AM-9:00 AM in vitro P5-03-08 Eribulin impairs the transport of Poster Session: P5-03-08 TGF-ss type I receptor leading to Date: Friday, December 11 inhibition of downstream non-canonical Time: 5:00 PM-7:00 PM TGFss signaling necessary for cancer metastasis and survival P5-03-09 Eribulin affects E-cadherin Poster Session: P5-03-09 localization consistent with a reversal Date: Friday, December 11 of the epithelial-to-mesenchymal Time: 5:00 PM-7:00 PM transition P1-14-04 A Randomized Phase II Neoadjuvant Study Poster Session: P1-14-04 of Sequential Eribulin Followed by Date: Wednesday, December 9 FAC-Regimen Compared to Sequential Time: 5:00 PM-7:00 PM Paclitaxel Followed by FAC/FEC-regimen in Women with Early Stage Breast Cancer Not Overexpressing HER-2 P6-13-17 The combination of eribulin and Poster Session: P6-13-17 everolimus results in enhanced Date: Saturday, December 12 suppression of tumors in mouse models Time: 7:30 AM-9:00 AM of triple negative breast cancer P3-07-66 Efficacy and gene expression results Poster Session: P3-07-66 from eribulin SOLTI1007 neoadjuvant Date: Thursday, December 10 study Time: 5:00 PM-7:00 PM P1-12-04 A phase 2 study of eribulin in breast Poster Session: P1-12-04 cancer not achieving a pathologic Date: Wednesday, December 9 complete response (pCR) to neoadjuvant Time: 5:00 PM-7:00 PM chemotherapy (NAC) P1-14-06 A phase II randomized study with Poster Session: P1-14-06 eribulin/cyclophosphamide (ErC) and Date: Wednesday, December 9 docetaxel/cyclophosphamide (TC) as Time: 5:00 PM-7:00 PM neoadjuvant therapy in HER2-negative breast cancer- Final analysis of primary endpoint and correlative analysis results P6-13-21 Phase 1 study of GR antagonist Poster Session: P6-13-21 mifepristone (M) in combination with Date: Saturday, December 12 eribulin (E) in advanced solid tumors, Time: 7:30 AM-9:00 AM with dose expansion in patients (pts) with GR-positive triple-negative breast cancer (TNBC) P1-03-09 Pegylated Recombinant Human Poster Session: P1-03-09 Hyaluronidase PH20 (PEGPH20) Enhances Date: Wednesday, December 9 Efficacy of Eribulin Mesylate Time: 5:00 PM-7:00 PM (HALAVEN(R)) in Triple Negative Breast Cancer Xenografts OT3-02-05 Phase II study of eribulin in Poster Session: OT3-02-05 combination with gemcitabine for the Date: Friday, December 11 treatment of patients with locally Time: 5:00 PM-7:00 PM advanced or metastatic triple negative breast cancer. ERIGE Trial on behalf of the Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC) P1-10-06 Nausea control and quality-of-life Poster Session: P1-10-06 benefit with NEPA, the first Date: Wednesday, December 9 combination antiemetic agent, in Time: 5:00 PM-7:00 PM patients with breast cancer receiving anthracycline/cyclophosphamide (AC) chemotherapy
Some of the information discussed in this release is about investigational uses for eribulin.
Eisai is dedicated to discovering, developing and producing innovative oncology therapies that can make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission, which strives for better understanding of the needs of patients and their families to increase the benefits health care provides.
Notes to Editors
Eisai in Oncology
Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, therapeutic vaccines, and biologic and supportive care agents for cancer across multiple indications.
Eribulin is the first in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action. Structurally eribulin is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Eribulin is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in multiple therapeutic areas with high unmet medical needs, including Oncology and Neurology.
As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.
For more information about Eisai Co., Ltd., please visit http://www.eisai.com.
1. SPC Halaven (updated November 2015). Available at: http://www.medicines.org.uk/emc/medicine/24382 . Last accessed November 2015
Date of preparation: November 2015 Job code: Halaven-UK0452
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